PANTAKIND-40 (Pantoprazole)

Pantakind-40 is a medication that contains the active
ingredient pantoprazole, which belongs to a group of drugs known as proton pump
inhibitors (PPIs). It is used to treat a variety of conditions related to
excessive stomach acid production, including gastroesophageal reflux disease
(GERD), peptic ulcers, and Zollinger-Ellison syndrome. Pantoprazole works by
reducing the amount of acid produced in the stomach, thereby reducing the
symptoms associated with these conditions. Pantakind-40 is typically taken
orally, and the dosage may vary depending on the condition being treated and
the individual patient’s needs. It is important to follow the prescribing
physician’s instructions carefully when taking this medication, as improper use
can lead to unwanted side effects.

Proton Pump
Inhibitors, ATC code: A02B C02

Therapeutic
Indications

Dosage &
Administration

Benign Gastric Ulcer:
Adult over 18 years, 40-80 mg daily in the morning for 4 weeks, continued for
further 4 weeks if not fully healed.

Gastro-oesophageal
Reflux Disease: Adult and children over 12 years, 20-80 mg daily in the
morning for 4 weeks, continued for further 4 weeks if not healed; maintenance
20mg daily, increased to 40 mg if symptoms return.

Duodenal ulcer: Adult over 18 years, 40-80 mg daily in the
morning for 2 weeks, continued for further 2 weeks if not fully healed.

Prophylaxis of NSAID-associated gastric and duodenal ulcer
in patients with an increased risk of gastroduodenal complications who require
continued NSAID treatment: Adult over 18 years, 20mg daily.

Zollinger-Ellison syndrome (and other hypersecretory
conditions): Adult over 18 years, initially 80 mg once daily and adjusted
according to response (Elderly max, 40mg daily); daily doses above 80mg given
in 2 divided doses.

Mode of
administration

Tablet should be swallowed as whole with or without food
& it should not be split, chewed, or crushed.

Contraindications

PANTAKIND-40 is contraindicated in patients with known
hypersensitivity to any component of the formulation or any substituted
benzimidazole.

Special warnings and
precautions

In patients with severe hepatic impairment, the liver
enzymes should be monitored regularly during treatment with Pantoprazole,
particularly for long-term use.

In presence of any alarm symptom (e.g. significant
unintentional weight loss, recurrent vomiting, dysphagia, haematemesis, anaemia
or malaena) and when gastric ulcer is suspected or present, malignancy should
be excluded, as treatment with pantoprazole may be alleviate symptoms and delay
diagnosis. Further investigation is to be considered if symptoms persist
despite adequate treatment.

Co-administration of atazanavir with proton pump inhibitor
is not recommended. If the combination of atazanavir with a proton pump
inhibitor is judged unavoidable, dose clinical monitoring (e.g. virus load) is
recommended in combination with an increase in the dose of atazanavir to 400mg
with 100mg of ritonavir. A pantoprazole dose of 20mg per day should not be
exceeded.

In patients with Zollinger-Ellison syndrome and other
pathological hypersecretory conditions requiring long term treatment,
pantoprazole, as all aacid-blocking medicines, may reduce the absorption of
vitamin B12 (cyanocobalamin) due to hypo-or achlorhydria. This should be
considered in patients with reduced body stores or risk of factors for reduced
vitamin B12 absorption on long-term therapy 
or if respective clinical symptoms are observed.

In long term treatment, especially when exceeding a
treatment period of 1 year, patients should be kept under regular surveillance.

Pantoprazole, like all proton pump inhibitors (PPIs), might
be expected to increase the counts of bacteria normally present in the upper
gastrointestinal tract. Treatment with Pantoprazole 40mg may lead to slightly
increased risk of gastrointestinal infections caused by bacteria such as Salmonella and Campylobacter.

Several published observational studies suggest that proton
pump inhibitor (PPI) therapy may be associated with an increased risk for
osteoporosis-related fractures of the hip, wrist or spine. The risk of fracture
was increased in patients who received high-dose, defined as multiple daily
doses, and long-term PPI therapy (a year or longer). Patients should use the
lowest dose and shortest duration of PPI therapy appropriate to the condition
being treated.

PANTAKIND-40
contains Lactose and hence patients with rare hereditary problems of fructose
intolerance should not take this medicine. It also contains Propylene glycol
which may cause skin irritation.

Interactions with
other medicinal products and other form of interaction

Because of profound and long lasting inhibition of gastric
acid secretion, pantoprazole may reduce the absorption of medicinal drugs with
a gastric pH-dependent bioavailability (e.g. some azole antifungals such as
ketoconazole, itraconazole, posaconazole and other medicines such as
erlotinib).

Co-administration of atazanavir and other HIV medications
whose absorption is pH-dependent with proton pump inhibitors might result in a
substantial reduction in the bioavailability of these HIV medications and might
impact the efficacy of these medicines. Therefore, co-administration of proton
pump inhibitors with atazanavir is not recommended.

There have been post-marketing reports of increased INR and
prothrombin time in patients receiving proton pump inhibitors, including
Pantoprazole and Warfarin concomitantly. Increase in INR and prothrombin time
may lead to abnormal bleeding and even death. Patients treated with proton pump
inhibitors and warfarin concomitantly should be monitored for increases in INR
and prothrombin time.

Pregnancy and
lactation

Use in pregnancy:
Pregnancy category B. There are no adequate and well-controlled studies of
pantoprazole in pregnant women. Pantoprazole should be used during pregnancy
only if the potential benefit justifies the potential risk to the foetus.

Use in lactation:
There are no adequate and well controlled studies of pantoprazole in lactating
women and hence should be used only if clearly indicated.

Effects on ability to
drive and use machines

Adverse drug reactions such as dizziness and visual
disturbance may occur. If affected, patients should not drive or operate
machines.

Undesirable Effects

Side-effects of the proton pump inhibitors include
gastro-intestinal disturbances including nausea, vomiting, abdominal pain,
flatulence, diarrhea, constipation, and headache. Less frequent side-effects
include dry mouth, peripheral oedema, dizziness, sleep disturbances, fatigue,
paraesthesia, arthragia, myalgia, rash and pruritus.

Overdosage

Experience in patients taking very high dose of Pantoprazole
(>240mg) is limited. Pantopraazole is not removed by hemodialysis. In case
of overdosage, treatment should be symptomatic and supportive.

Single oral doses of Pantoprazole at 709mg/kg, 798mg/kg and
887mg/kg were lethal to mice, rats and dogs, respectively.

The symptoms of acute toxicity were hypoactivity, ataxia,
hunched sitting, limb-splay, lateral position, segregation, absence of ear
reflex and tremor.

Pharmacological
Properties

Pantoprazole is a substitute benzimidazole which inhibits
gastric acid secretion of hydrochloric acid in the stomach by specific blockage
of  the proton pumps of the parietal
cells.

Pantoprazole is converted to its active form in the acidic
environment in the parietal cells where it inhibits the H+, K+-ATPase enzyme,
i.e. the final stage in the production of hydrochloric acid in the stomach. The
inhibition is dose-dependent and affects both basal and stimulated acid
secretion. As with other proton pump inhibitors and H2 receptor inhibitors,
treatment with pantoprazole reduces acidity in the stomach, there by increases
gastrin in proportion to the reduction in acidity. The increase in gastrin is
reversible. Since pantoprazole binds to the enzyme distal to the cell receptor
levels, it can inhibit hydrochloric acid secretion independent of stimulation
by other substances (acetylcholine, histamine, gastrin).